MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	PN-0006000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tablo instructions for use (ifu) warning and caution: monitor patient¿s blood pressure and general physical status during treatment and initiate appropriate remedial measures or therapy.Particularly monitor and control the patient¿s serum potassium level to prevent cardiac dysrhythmia and the patient¿s blood clotting time to prevent clotting disorders.Outset field service engineer (fse) reviewed the system log with the procedure date (b)(6) 2026 and confirmed alarm_venous_pressure_high.No console-related malfunctions or performance issues were identified.A review of production records for this serial number did not note any related manufacturing nonconformances that would contribute to this event.
Event or Problem Description
The caller reported that the saline bag ran dry approximately 45 minutes into treatment, resulting in air in the venous bloodline.The user ended the treatment and was unable to return the patient¿s blood.The cartridge and saline bag were replaced, and treatment was restarted.During the restart, the patient¿s access line clotted, leading to a second instance of being unable to return the patient¿s blood.Approximately 480cc of blood was lost.No patient adverse event was noted as a result of this event.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• Manufacturer (Section G): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• Manufacturer Contact: dinamarie stefani ; 3052 orchard drive; san jose, CA 95134 ; 6692318200
• MDR Report Key: 24506795
• Report Number: 3010355846-2026-00026
• Device Sequence Number: 9943577
• Product Code: KDI
• UDI-Device Identifier: 00850001011204
• UDI-Public: (01)00850001011204(11)231215
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PN-0006000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown